To determine the efficacy and safety of Inj Diclofenac 75mg/ml given intradeltoid with Injection Diclofenac 75mg/3ml given intragluteal in the management of postoperative pain in obese patients.

Phase 4

Completed

Conditions: Post Operative Pain

Registration Number: CTRI/2009/091/000108

Lead Sponsor: Troikaa Pharmaceuticals Limited

Brief Summary: Non steroidal anti inflammatory drugs are alternatives to opioids as sole analgesic after minor surgery or as adjuvant to opioid analgesics following major surgery. One of the most commonly used NSAID for postoperative pain is diclofenac. Currently injection diclofenac is available as a 3 ml formulation and needs to be given deep intra-muscular usually intra-gluteal. A new formulation of injection diclofenac with reduced injection volume (1ml) has recently become available for clinical practice. Due to a lower injection volume it can also be given intra-deltoid. The aim of the study is to compare the efficacy and safety of the newer 1 ml formulation of injection diclofenac with the existing formulation in the management of post operative pain in obese patients.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 200

Inclusion Criteria

Patients in the age group of 18 to 65 years Patients of both sexes Patients with BMI greater or equal to 25 Patients undergoing operative procedures requiring hospitalization for at least 48 hours Patients with moderate to severe pain at baseline VAS 4 to10.

Exclusion Criteria

1.Patients below 18 years and above 65 years of age2.Patients with BMI < or = 253.OPD patients/ patients requiring hospitalization less than 48 hours4.Patients with compromised renal function5.Pregnant and lactating women 6.Patients with history of bronchial asthma, peptic ulceration, bronchitis7.Patients with coagulation disorders, especially bleeding disorders8.Mentally retarded patients9.Unwilling patients10.Patients with known hypersensitivity to propylene glycol, diclofenac sodium any other NSAIDs or any component of either of the study formulations11.Patients with a baseline VAS score of 3 or less than 3.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of pain relief, as assessed by a 5- point scale by patients	At the end of 1, 4, 8 and 12 hours as compared to basal after each dose.

Secondary Outcome Measures

Name	Time	Method
Physicians evaluation of swelling, redness and induration at the site of injection	After each dose
Global efficacy by patients and investigator.	End of Study (After 48 hrs)
Systemic Adverse Reactions and Rescue Medication	Upto 48 hours.
Pain at the site of injection as assessed by visual analogue scale (VAS)	At 1 hour and 12 hours after each dose.

Trial Locations

Locations (2): Chhatrapati Shahuji Maharaj Medical University, U. P.
🇮🇳
Lucknow, UTTAR PRADESH, India
Hardikar Hospital
🇮🇳
Pune, MAHARASHTRA, India
Chhatrapati Shahuji Maharaj Medical University, U. P.
🇮🇳Lucknow, UTTAR PRADESH, India
Dr. JaishrI Bogra,
Principal investigator
09839075895
jaishri.bogra@gmail.com